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Normal range for haemoglobin A1c (HbA1c), fructosamine and fasting blood glucose in different trimester of pregnancy in non-diabetic Hong Kong pregnant population

To determine the trimester-specific reference intervals for haemoglobin A1c (HbA1c), fructosamine and fasting blood glucose in non-diabetic Hong Kong pregnant population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000273684
Enrollment
400
Registered
2014-03-14
Start date
2014-02-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The increased risk of adverse pregnancy outcome is related to glycaemic control, which can be monitored by glycated haemoglobin (HbA1c). HbA1c can identify the average blood glucose concentration over the previous months prior to the measurement. The correlation between HbA1c levels and clinical outcomes depends on appropriately-defined reference intervals, which have not been defined in Hong Kong pregnant women. Fructosamine can also be useful in monitoring the effectiveness of therapy in diabetes, in a manner analogous to the HbA1c. It reflects the glycaemic control over the past 2 – 3 weeks. Therefore it can determine the effectiveness of gestational diabetes mellitus (GDM) treatment earlier compare with HbA1c, which may improve pregnancy outcome in patients with GDM. However, there is only limited experience in use of fructosamine in patients with GDM. Therefore, there is a need to establish trimester-specific reference intervals of HbA1c, fructosamine and fasting blood glucose in non-diabetic pregnant women in the local population, which may be useful in guiding treatment for GDM and diabetes mellitus in pregnancy.

Interventions

To determine the trimester-specific reference intervals for HbA1c, fructosamine and fasting glucose in non-diabetic pregnant women, serum samples will be collected once per trimester. In order to minimize inconvenience to subjects, serum sample collection in first trimester will be done at the time of first trimester Down screening. Serum sample collection in second trimester will be done at the time of oral glucose tolerance test. Serum sample collection in third trimester will be done at 34 –

To determine the trimester-specific reference intervals for HbA1c, fructosamine and fasting glucose in non-diabetic pregnant women, serum samples will be collected once per trimester. In order to minimize inconvenience to subjects, serum sample collection in first trimester will be done at the time of first trimester Down screening. Serum sample collection in second trimester will be done at the time of oral glucose tolerance test. Serum sample collection in third trimester will be done at 34 – 37 weeks gestation during antenatal visit, together with serum sample collection for other purpose if possible.

Sponsors

Dr Lee Hui Ling Helena
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

Non-diabetic pregnant women who attend the first trimester Down screening (at 11 to 13+6 weeks gestation) in Queen Elizabeth Hospital, Hong Kong Patients who signed written informed consent in Chinese or English version

Exclusion criteria

Patient with pre-existing diabetes mellitus Patient refusal Inability of patient to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026